The impact of China’s national essential medicine system on improving rational drug use in primary health care facilities: an empirical study in four provinces

Rational drug use (RDU) requires that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community [1]. However, all countries, both rich and poor, have encountered problems with the insufficient use of beneficial, cost-effective drugs and the over use of unnecessary drugs. According to a World Health Organization (WHO) report, more than 50% of all medicines were prescribed, dispensed, or sold inappropriately worldwide, and 50% of patients failed to take their medicines correctly [2]. The medically inappropriate and economically inefficient use of drugs also occurs frequently in China. The consumption of intravenous fluids was estimated at eight bottles per person in China in 2009, a figure much higher than the overall global level (2.5-3.3 bottles). The overuse of antibiotics is another common form of medicine abuse in China. China is one of the heaviest users of antibiotics, with 70% of prescriptions containing antibiotics [3].

In China, hospitals can charge 15% over the wholesale price for drugs. This drug mark-up was initially introduced to compensate facilities for providing services below cost, as stipulated in the required fee schedule set by the government. However, this compensatory practice induced serious health hazards and encouraged physicians to over-prescribe unnecessary medicines, especially those that were more expensive or profitable. In 2009, the cost of drugs in China was 766 billion yuan, accounting for 41% of the total medical cost, and the cost of drugs per capita was 574 yuan [4]. The irrational use of medicines has resulted in not only a waste of resources but also adverse drug reactions (ADRs), drug resistance and increased drug-related morbidity and mortality [5]. It was estimated that about 2.5 million patients each year were admitted to the hospital owing to serious ADRs, and 60% of cases of acquired deafness in children were caused by irrational use of ototoxic drugs [6].

In 2009, increasing concerns regarding the appropriateness of medicinal drug use and access to safe and effective essential medicines led the Chinese government to introduce the National Essential Medicine System (NEMS) for public primary health care facilities, with the intention of extending it to private providers and hospitals. This program was a new policy in China and advocated prioritizing the use of essential medicines and the rational use of essential medicines. The program’s key objectives included removing the profit link between health institutions, doctors, and medicines and the improvement of medicine use. The core of the program was the Essential Drug List (EDL), which included selected low-cost medicines for common treatable diseases affecting vast numbers of people. The list for primary health care facilities contained 307 generic medicines (205 Western medicines and 102 traditional Chinese medicines). All public primary health care settings were required to stock and prescribe only drugs from the EDL and to sell them at cost (zero-profit drug policy). Clinical treatment guidelines and formulas for the administration of essential medicines were developed to regulate the behavior of health workers. Local social health insurance programs (including the New Rural Cooperative Medical Scheme) covered all essential medicines and provided a higher reimbursement for listed drugs than for non-listed drugs. However, different provinces varied in terms of the reimbursement rate.

To date, the initial three-year implementation plan has been realized. Clearly, there is a need to investigate the outcomes of the NEMS objectives with the further aim of contributing to the continued improvement of the system. Consequently, the purpose of this study was to examine the outcomes resulting from NEMS in terms of rational drug use in primary health care facilities and to provide up-to-date evidence and policy implications for the way forward.

The township health center plays an important role in providing primary health care services to the large population in rural China. The findings of this study may provide quantitative baseline data for monitoring and improving prescribing processes and rational drug use in China.

First, our study revealed that significantly fewer drugs were prescribed per prescription after China’s implementation of the NEMS (p <0.01). In 2010, patients were prescribed an average of 3.46 drugs per prescription, which was however still double the derived WHO standard value of 1.6-1.8 [10]. It was also higher than the average of 2.2 drugs prescribed per patient visit found in a study of 17 developing countries, where the highest national average was 3.8, found in Indonesia and Nigeria [11]. Thus, our study indicates that the trend towards polypharmacy persisting in China was among the world’s most severe cases. Furthermore, we found that about 27.24% prescriptions contained five or more different kinds of drugs in 2010; the highest number was 32 drugs for a single prescription. Multi-drug use may increase the risk of undesirable drug interactions and needs more attention.

Following the implementation of the NEMS, all THCs were required to stock and prescribe drugs solely from the EDL and to sell them at cost, a policy aimed at ending the interest link between physicians and drugs and reducing incentives for health care providers to over-prescribe. The current trend towards polypharmacy may be attributed to patients’ demands; patients believe that prescribing more drugs will ensure improvement and facilitate the cure of their conditions more quickly [12]. Another contributing factor could be that the treatment is based purely on symptoms instead of a full diagnosis. Though clinical treatment guidelines and formulas for essential medicines have been developed, they have not yet been fully accepted or followed by physicians in THCs. Another possible factor could be that ‘bargain mentality’ encourages irrational use. For example, in Ningxia, there is an annual medical compensation for outpatient services (about 30 yuan per person). Patients prefer to get medicines for free and always pressure prescribers to prescribe medicines within the quota, especially at the end of the fiscal year, regardless of whether they need these drugs or not. Thus, RDU education for both health care providers and consumers should be further promoted.

Second, analysis of the data revealed that essential medicines constitute a reasonably high proportion of all medicines prescribed in THCs after the implementation of the NEMS. On average, 80% of the drugs prescribed appeared on the EDL in 2010. The priority use of essential medicines is worth advocating. However, doctors in primary health care facilities should not be limited to prescribing only essential medicines and should have some scope for autonomy within a certain range. It is rare for a country to reduce medicine costs and promote rational medication by controlling the prescription practices of doctors with an EDL covering a few medicine categories. This rarity is because of the specificity of the medical industry and the individual variations within it across contexts [13].

Third, our study showed that the number of prescriptions where one or more antibiotics were prescribed decreased to 58.48% in 2010 (p <0.01), whereas the WHO recommendation is 20.0-26.8% [8]. Moreover, the proportion containing more antibiotics increased somewhat, and the mean number of antibiotics per prescription has not changed. Antibiotics are essential, but their overuse can increase antibiotic resistance, which will endanger their therapeutic effectiveness, increase treatment failure, and, as a result, lead to longer and more severe illness episodes associated with higher costs and an increased mortality rate [14]. The major factors reported to influence the high percentage of antibiotics prescribed elsewhere are physicians’ lack of knowledge about appropriate antibiotic use, including the overestimation of the severity of the illness to justify prescribing an antibiotic, and pressure from patients who believe that antibiotics provide rapid symptomatic relief from disease [15],[16]. The same factors may play a role in China. Hence, follow-up research should focus on the improvement of the use and management of antibiotics. There is also an urgent need for public education.

Fourth, our results showed that the use of injections and adrenal corticosteroids improved significantly after the implementation of the NEMS. However, the overall percentage of prescriptions containing injections in Shandong and Ningxia in 2011 was 24.4%, still higher than the percentage reported previously in 35 developing countries (22.8%) [17]. In China, the mistaken belief that ‘Injections mean you will get well sooner’ has always caused patients to request injections [18]. Compared with oral drug therapy, injections are more expensive because of the additional cost of syringes, sterilization control, and well-trained personnel. In addition to increasing the economic burden of patients, overuse of injections brings risks of unsafe needles that can increase the transmission of AIDS, hepatitis B and C, and other blood-borne diseases [19]. Most notably in our survey, 23.12% of injections prescribed were antibiotics, potentially increasing the risk of antibiotic resistance.

Finally, the cost analysis in Shandong and Ningxia revealed that the total medical cost per prescription significantly increased between 2009 and 2011. With the price control policy of the NEMS, medicine prices in 2011 were reduced by 25% from 2009 prices [20]. However, medical costs did not fall correspondingly. The poor outcome might be partly caused by patients being treated with too many medicines, especially antibiotics. The results confirmed that the medical cost per prescription was higher with antibiotics or injections than that without, a finding that is consistent with other research [21]. Furthermore, a report from three Chinese provinces previously revealed that certain manufacturers ceased production of some essential drugs because the price controls and recommended procurement procedures in the NEMS severely curtailed their profits. The report also revealed that many health care providers complained that the prices they were paying for some drugs under the NEMS were higher than those they had paid before the NEMS was introduced in their facility [22]. These factors could be a contributor to rising medical costs. Additionally, the financial incentives that manufacturers provide to hospitals and doctors might also lead to the frequent use of medicines with higher prices due to the persistence of widespread corruption in the procurement process [23]-[25]. Where profits from selling drugs have been eliminated, appropriate financial compensation mechanisms are needed to ensure the sustainable development of the primary health care facilities, because drug revenue previously accounted for more than 50% of hospital revenue in China [26].

The results of this study should be interpreted in light of several limitations. First, China’s NEMS has recently been launched, and we collected post-implementation information soon after the introduction. Its effectiveness and impacts have not been fully realized, and there is limited empirical evidence to draw upon in making conclusions about its efficacy. Second, the results of this study were based only on four selected provinces. Although these four provinces were selected purposively to explore different development levels, the conclusions of this study should be generalized to the whole of China only with caution. Third, the prescription analysis conducted in this study only examined outpatient prescriptions and excluded inpatient prescriptions mainly owing to limited data availability.

In conclusion, most of the observed indicators in 2010 and 2011 have improved compared with 2009. There was a positive association between the NEMS and the more appropriate use of medications in primary health care settings in China. However, polypharmacy and the over-prescription of antibiotics and injections remain common. At the time of our data collection, the RDU indicators had not yet met the WHO Standard Guidelines. The NEMS agenda remains largely unfinished, and its realization requires further policy improvements. In light of this need for future improvements, we provide some recommendations based on the above findings and discussion. First, treatment guidelines should be highlighted and closely followed. Health delivery systems should routinely assess medicine use to encourage rational prescription. Next, the concept of rational drug use should be incorporated into the basic and continuing education of health care providers. Finally, it is necessary to improve training on RDU for consumers to gradually change their mistaken beliefs and thus reduce their demand for drugs that do not bring additional health benefits.

Written informed consent was obtained from the patient for the publication of this report and any accompanying images.

YB designed the study. YS, LL, and AY contributed to the interpretation of the data. YS and YB drafted the manuscript. MP performed the statistical analysis and reviewed initial drafts of the manuscript. All authors read and approved the final manuscript.